ANI-Guided Anesthetic Desflurane Consumption

NCT06982209 | Completed DMC

• 1 other identifier: Wonkwang UH20
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

General anesthesia requires precise titration of inhaled anesthetics like desflurane and opioids like remifentanil to balance sedation, analgesia, and hemodynamic stability. The Analgesia/Nociception Index (ANI), derived from heart rate variability (HRV), quantifies parasympathetic tone to assess nociception-antinociception balance on a 0-100 scale, with lower values indicating nociceptive stress. ANI analyzes high-frequency HRV components, reflecting parasympathetic inhibition during painful stimuli, making it a reliable indicator of intraoperative nociception. Studies validate the utility of ANI in detecting nociceptive events during laparoscopic surgery. ANI-guided opioid titration reduces opioid consumption and stabilizes hemodynamics, enhancing perioperative outcomes.

Conditions

Postoperative Pain; General Anesthesia; Laparoscopic Cholecystectomy

Outcome Measures

Primary Outcomes (1)

• Mean End-Tidal Desflurane Concentration

  The average end-tidal desflurane concentration (Vol%) during maintenance of general anesthesia, measured using continuous gas monitoring. Desflurane delivery is titrated based on ANI (Analgesia/Nociception Index) in the intervention group and based on vital signs in the control group.

  From induction of anesthesia to end of surgery (approximately 60 minutes)

Secondary Outcomes (5)

• Emergence Time

  At the end of surgery until eye opening (approximately 5-15 minutes)

• Post-Anesthesia Care Unit (PACU) Length of Stay

  From PACU entry to PACU discharge criteria fulfillment (approximately 30-90 minutes)

• Additional Analgesic Requirement in PACU

  During PACU stay (up to 2 hours after surgery)

• Incidence of Postoperative Nausea and Vomiting (PONV)

  Within 2 hours after surgery

• Patient Satisfaction

  At PACU discharge and 24 hours postoperatively (POD1)

Study Arms (2)

ANI-guided group

EXPERIMENTAL

Desflurane started at 1 MAC (\~6 Vol%), titrated in 0.1 MAC increments to maintain ANI 50-70 and BIS 40-60. ANI \<50 prompted an increase; ANI \>70 prompted a decrease

Device: Analgesia/Nociception Index (ANI)

Control group

ACTIVE COMPARATOR

Desflurane was titrated based on vital signs (heart rate, blood pressure) and BIS 40-60, per institutional protocol.

Device: Analgesia/Nociception Index (ANI)

Interventions

Analgesia/Nociception Index (ANI) DEVICE

ANI was monitored using the ANI monitor (MetroDoloris, France) in both groups, but only guided adjustments in the ANI group

ANI-guided group; Control group

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 19-65 years, American Society of Anesthesiologists (ASA) physical status I-II, scheduled for elective laparoscopic cholecystectomy under general anesthesia.

You may not qualify if:

• chronic pain, preoperative opioid use, cardiac arrhythmias, autonomic dysfunction, or contraindications to desflurane or remifentanil.

Sponsors & Collaborators

• Wonkwang University Hospital: lead

Study Sites (1)

Wonkwang University School of Medicine Hospital

Iksan, Jeollabuk-do, 54538, South Korea

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Analgesia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Study Officials

• Cheol Lee, M.D.,Ph.D

  Wonkwang University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participants, care providers (excluding anesthesiologists), and outcome assessors were blinded to group allocation. Anesthesiologists administering anesthesia were unblinded due to the requirement for ANI monitoring and titration in the intervention group. Outcome assessors in the PACU were independent staff blinded to intraoperative management.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: * ANI Group: Desflurane started at 1 MAC (\~6 Vol%), titrated in 0.1 MAC increments to maintain ANI 50-70 and BIS 40-60. ANI \<50 prompted an increase; ANI \>70 prompted a decrease. * Control Group: Desflurane was titrated based on vital signs (heart rate, blood pressure) and BIS 40-60, per institutional protocol.

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: May 21, 2025
• Study Start: February 5, 2024
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2025
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)